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

Catalog Number 306595

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: two samples were received for evaluation.They are in a disposable plastic glove.They are with no packaging flow wrap.Both have the plunger rod- rubber stopper, the tip cap and saline solution.The barrel label confirms the lot#7173520.Both syringes have a barrel crack towards the bottom part.One has ¾¿ length and the other crack has 1 3/8 ¿length.Failure mode is verified.Possible root cause for the barrel crack could be the diverter right before the packaging flow wrapper, or that the packaged product experienced excessive compression force.At this time, we have no evidence for any of these two possible root causes as all our inspections performed while manufacturing this batch were accepted; no rejections were documented.A device history review was completed with the following results: there were no issues documented during the production of this batch for barrel/flange damage.Dhr/bhr review: there were no issues documented during the production of this batch for barrel/flange damage.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update 4/06/2018.Two samples were received.They are in a disposable plastic glove.They are with no packaging flow wrap.Both have the plunger rod- rubber stopper, the tip cap and saline solution; the barrel label confirms the lot#7173520.Both syringes have a barrel crack towards the bottom part.One has ¾¿ length, and the other crack has 1 3/8 ¿length.Product within specification? yes; no.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 was no issue documented about barrel/flange damaged.Capa not required for this event.

Event Description

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

• 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: 7411185
• MDR Text Key: 105243919
• Report Number: 1911916-2018-00139
• 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,other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7173520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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