MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306595

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: no issues were documented about fm of any type associated with this batch 7079993.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure mode investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.On (b)(6) 2017.Two samples were received.They are with no packaging flow wrap.The barrel labels confirms the lot# 7079993.They are full of saline fluid.The fm is located in the saline on the top part of the syringe.On both syringes the plunger rod/ stoppers are not secure by the retaining ring.One sample shows entrapped fluid that bridges across ribs.The saline was tested for flush % label and both passed.The fm was removed from both syringes, confirming them as piece of packaging flow wrap material.We have 100% inspection and this fm would have been detected if they were there at the inspection time.Having the plunger rod all the way up it would have been detected by our plunger rod labeler and it would had been damaged by our doboy process, no damages are noticed to the samples.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 issues documented about fm.Our 100% inspection is capable to detect the fm.The plunger rod labeler is capable to detect the position of the plunger rod/stopper.The material of this fm is plastic flow wrap.The location of the fm confirms that these syringe are not representative of our manufacturing process; we have controls in place to detect this type of fm and plunger rod position.Based on the characteristics of these samples we are not able to confirm the root cause.Capa determination results n/a.Dhr/bhr review no issues were documented about fm of any type associated with this batch 7079993.Capa determination results n/a.(b)(4).

Event Description

It was reported that foreign matter was found in the 10 ml bd posiflush¿ normal saline syringe before use.No reported medical intervention or serious injury.

• Brand Name: 10 ML 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: 6842654
• MDR Text Key: 85624816
• Report Number: 1911916-2017-00228
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2017

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
• Device Operator: Nurse
• Device Catalogue Number: 306595
• Device Lot Number: 7079993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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