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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS HUBER PLUS 20G X 1" NEEDLELESS Y SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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. ".
 
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Brand NameHUBER PLUS 20G X 1" NEEDLELESS Y SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key8629087
MDR Text Key145753460
Report Number3006260740-2019-01435
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K993848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number012001NY
Device Lot NumberRECS1872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/21/2019 Patient Sequence Number: 1
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