MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X 1" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Vomiting (2144); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs1872 showed no other similar product complaint(s) from this lot number.

Event Description

"it was reported that on (b)(6) 2019 patient arrived back on ward from mri at 14:00.Patient was in wheel chair and fell off wheelchair, when getting up line pulled from iv pole to patient, (b)(6) (mother) noted there was blood in the iv line from the port, buzzed for nursing staff, nursing staff flushed port, patient was unsettled at this time and upset and reporting pain from port.Post flush (b)(6) noted patient to still have flash back of fresh blood in line from port within a few minutes of flushing n/saline.(b)(6) buzzed again for the fresh blood in the line, nursing staff attended and clinical decision to hep lock the port.It was noted by mother that at this time no nursing staff member had visualized the port.Friday am.Patient was playing on couch and brushed up against the couch and c/o pain from port site, (b)(6) buzzed for nursing staff to access pain and also port, port not viewed and suggestion of panadol.(b)(6) declined paracetamol.(b)(6) asked for port to be de-needled to see if it could assist in decreased of pain.Nursing staff liaised with team and decision made to leave port accessed until pt for d/c.Friday mid morning, team review pt and happy for d/c, port de-needled, during this process 3 x nursing staff for de-needle procedure.Pt was quite upset.(b)(6) felt that this was different to previous de-needles, as pt was very upset and distressed with removal of tape.When needle was removed (b)(6) was a bit concerned due to site of port she voiced that she felt site appeared to be different then previous de-needles.Spoke to nursing staff about concerns about redness and puffiness asked if this was normal around port site and nursing staff offered (b)(6).Pt discharged, (b)(6) was concerned about port so took a photo for own record to monitor.Friday night, family drove back to (b)(6), pt c/o pain on port site during drive home.Once home pt vomited post medication when parents removed clothes noted bump and increased redness to port site, (b)(6) felt port and thought the needle was still in port.(b)(6) presented to (b)(6) for review in high care unit, pt had to have 2 x-rays of chest, which confirmed that needle was still in port.Pt then advised to present to the hospital, for review and to fast for revision of port.Presented to ed and fasted and port revised in ot.Port able to be kept.Contributing factors port site not visualised during admission, when (b)(6) de-needled first time post fall from wheel chair, the parents are quite concerned due to the fact the post this was just hep locked and not physically the dressing removed and looked at.Concerns voiced by parents in regards to different appearance of port not reviewed or escalated.During de - needle (b)(6) raised concerns and was worried about appearance and only offered panadol and band-aid.Removal of needle under general anaesthetic.".

Event Description

"it was reported that on thursday (b)(6)2019 patient arrived back on ward from mri at 14:00.Patient was in wheel chair and fell off wheelchair, when getting up line pulled from iv pole to patient, mo (mother) noted there was blood in the iv line from the port, buzzed for nursing staff, nursing staff flushed port, patient was unsettled at this time and upset and reporting pain from port.Post flush mo noted patient to still have flash back of fresh blood in line from port within a few minutes of flushing n/slaine.Mo buzzed again for the fresh blood in the line, nursing staff attended and clinical decision to hep hep lock the port.It was noted by mother that at this time no nursing staff member had visualized the port.Friday am.Patient was playing on couch and brushed up against the couch and c/o pain from port site, mo buzzed for nursing staff to access pain and also port, port not viewed and suggestion of panadol.Mo declined paracetamol.Mo asked for port to be de-needled to see if it could assist in decreased of pain.Nursing staff liaised with team and decision made to leave port accessed until pt for d/c.Friday mid morning, team review pt and happy for d/c, port de-needled, during this process 3 x nursing staff for deneedle procedure.Pt was quite upset +++ mo felt that this was different to previous deneedles, as pt was very upset and distressed with removal of tape.When needle was removed mo was a bit concerned due to site of port she voiced that she felt site appeared to be different then previous de-needles.Spoke to nursing staff about concerns about redness and puffiness asked if this was normal around port site and nursing staff offered band-aid.Pt discharged, mo was concerned about port so took a photo for own record to monitor.Friday night, family drove back to canberra, pt c/o pain on port site during drive home.Once home pt vomited post medication when parents removed clothes noted bump and increased redness to port site, fo felt port and thought the needle was still in port.Fo presented to tch for review in high care unit, pt had to have 2 x-rays of chest, which confirmed that needle was still in port.Pt then advised to present to the hospital, for review and to fast for revision of port.Presented to ed and fasted and port revised in ot.Port able to be kept.Contributing factors port site not visualised during admission, when quiery de-needled first time post fall from wheel chair, the parents are quite concerned due to the fact the post this was just hep locked and not physically the dressing removed and looked at.Concerns voiced by parents in regards to different appearance of port not reviewed or escalated.During de - needled mo raised concerns and was worried about appearance and only offered panadol and band-aid.Removal of needle under general anaesthetic.".

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set was confirmed, and the damage appeared to be associated with use of the device.No physical sample was returned for investigation.Instead, five photographs were provided by the complainant.Three of the photos showed what appeared to be the port insertion site, which showed redness in the area of what could have been the needle insertion site.One photograph was of a radiographic image on a computer monitor.What appeared to be consistent with the size and shape of a port and catheter were observed within the patient.What appeared to be consistent with a needle shaft was protruding from the area of the port septum.One photo showed an infusion set needle in proximity to what appears to be a broken needle shaft from a separate infusion set.The needle was determined to be broken since it did not contain the 90-degree bend.The broken needle appeared to be slightly bent near the midpoint of the shaft.The radiographic image and the photo of the broken needle indicate that the needle was most likely damaged during use.It was reported that the patient fell off a wheelchair, which may have been a contributing factor to the reported damage and associated effects.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recs1872 showed no other similar product complaint(s) from this lot number.

• Brand Name: HUBER PLUS 20G X 1" NEEDLELESS Y SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8629087
• MDR Text Key: 145753460
• Report Number: 3006260740-2019-01435
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741065569
• UDI-Public: (01)00801741065569
• Combination Product (y/n): N
• PMA/PMN Number: K993848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 012001NY
• Device Lot Number: RECS1872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention