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

Catalog Number 306594

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Investigation: a photo sample was reviewed by the columbus manufacturing plant.Upon review of the photo the engineer was able to determine that both of the syringes had a damaged barrel/flange verifying the failure mode.The engineer also noted that one syringe had a missing tip cap and that both were missing the packaging flow wrap.Based off of the photo provided the engineer concluded that the flange damage could have been caused by the plunger rod labeler equipment.The equipment has been verified and the adjustments of the infeed scroll and the reject station are correct.There were no quality issues found during the production of this batch.A dhr was performed and there were no documentation issues found for barrel/ flange damage for this batch.A picture was received.It shows two syringes.One has tip cap, the other it doesn't.Both have the plunger rod- rubber stopper and saline; both are with no packaging flow wrap.Both have barrel label confirming the catalog number 306594; the lot# cant be confirmed from the pictures.Both have the barrel flange damaged.Product within specification? yes, no.Root cause: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no parts damaged documented.

Event Description

It was reported that the flange of a bd posiflush¿ syringe was damaged.There was no report of exposure, injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ 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: 7314490
• MDR Text Key: 101711226
• Report Number: 1911916-2018-00076
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7159647
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other