MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306546

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7208530; medical device expiration date: 2020-07-31; device manufacture date: 2017-07-27; medical device lot #: 7164864; medical device expiration date: 2020-06-30; device manufacture date: 2017-06-13.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an rn from a user facility reported that blood was trapped in sections of the grey plunger and beyond into the syringe of a bd posiflush¿ normal saline syringe.This was noted when flushing the patient line.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Investigation summary: dhr/ bhr review: there was no documentation of issues for the complaint of batch 7164864 during this production run.All our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.On feb 26, 2018.Two photos were received.Both photos show two 10ml syringes; they both have the plunger rod- rubber stopper all the way down.There is no tip cap.From one of the syringes we can confirm the lot # 7164864.Both syringes show what appear to be blood between the rubber stopper ribs and past the stopper.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7228673
• MDR Text Key: 98849273
• Report Number: 1911916-2018-00010
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 306546
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other