MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SURESCRUB PRE-FILLED SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: three samples were received.They have the plunger rod-rubber stopper, only one has tip cap and all have barrel label; they have no packaging flow wrap.The plunger rod-rubber stopper is at 3.5ml, 5ml, and the third sample at 6ml.All three have solution.Visual inspection was performed, none of them has barrel deformation or any other type of damage.The sample with tip cap was tested for sustaining force from where the rubber stopper was given.The other two samples with no tip cap were checked for silicone dispersion finding them with poor silicone distribution at the bottom part of the syringe.Possible root cause, barrel silicone application.We can confirm the complaint from the fact that even when one sample was within spec for sustaining force, this was at the high side of the product specification; the other two were tested for silicone dispersion to understand why the first sample was on the high side of the specification.The silicone dispersion was the good enough.Note: after performing the sustain force we are unable to perform the silicone dispersion, since the rubber stopper would place some silicone on the inner barrel wall as it goes down during the test.These are escapes from the incident experienced while producing this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd posiflush¿ surescrub pre-filled syringe would cease up.This occurred on 3 occasions during use.The following information was provided by the initial reporter: material no.: 306559 batch no.: 9136939.It was reported that the pre-filled syringe would cease up because the stopper would stick and the barrel of the syringe was tapered.Pr 2 of 2: this pr is for incident that occurred "we had an isolated issue last week " we have 52 boxes of 30 each with the same lot.We had an isolated issue last week and the same issue arose again today 3 times.2 were back to back.When the iv was started and the nurses were going to flush, the prefilled syringes would cease up.The stopper would stick around the 7-8mm spot.It is almost like the syringe was tapered not to allow the plunger to advance any further.We only have 1 box of 30 on our shelf.

• Brand Name: BD POSIFLUSH¿ SURESCRUB PRE-FILLED SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9140790
• Report Number: 1911916-2019-01035
• Device Sequence Number: 19457607
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 306559
• Device Lot Number: 9136939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other