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

Catalog Number 306546

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

Results: one bd 10ml saline syringe from lot # 5237762 was returned for evaluation.The returned syringe was examined and exhibited dark material in the saline solution inside the barrel of the syringe.A microscopic inspection of the foreign matter revealed that the morphology of fine filaments (mycelium) along with the numerous small bead-like structures (spores) which are indicators of mold/fungus.The sample was then sent to the manufacturing site in (b)(4) and a secondary investigation was performed.The secondary investigation indicates that the returned sample was removed from its original packaging and was in a clear zip top poly bag.The barrel label batch # was not clearly legible; the only visible number being 52377 with two digits missing.It appeared like some friction to this area partially erased these two digits.The syringe showed fill volume overfilled.Our process usl is 10.4ml; the sample has 0.7ml volume overfilled.The plunger rod was not in its original position.It was all the way back not passing the retainer ring.(note, this sample was first received by bd (b)(4) complaints team and it was already like that).The syringe has fm floating in the saline.An ftir was performed and this fm match was: ideal yellow 77 wire pulling lubricant.We verified with our tool crib if this lubricant is bought by our company and the response was negative.We have 100% inspection and this fm would have been detected as well as the overfill volume, if they would be 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 be damaged by our doboy process, no damages are noticed to the sample.The flush % label test was performed to the fluid in the syringe.The test result was 3.4%.This concluded that water was in the syringe and not saline.Retention samples were also evaluated for flush % label testing.The results were: three (3) with 97.6%, three (3) with 97.4 and one with 97.3%.No mold was confirmed in our testing; the fm was confirmed as ideal yellow 77 wire pulling lubricant.A review of the device history record revealed no quality notifications for foreign matter associated with the reported lot # 5237762.There were no rejections documented for any foreign matter during this batch.All endotoxin testing and bioburden testing passed.Conclusion: although foreign matter was visualized and tested during the sample investigation, an absolute root cause for this incident cannot be determined.All inspections performed through the case pack were acceptable with no rejections recorded.There were no issues documented that would affect the syringe, the function or would induce the alleged mold issue.Our 100% inspection is capable to detect the fm and the overfill volume.The plunger rod labeler is capable to detect the position of the plunger rod/stopper.The yellow wire pulling lubricant material observed during the investigation is not used in our manufacturing site.The ftir and the flush % label test confirmed that this syringe is not representative of our process.We have controls in place to detect this type of foreign matter and plunger rod position.Additionally, we do not have pure water in our manufacturing process.Retention samples confirmed that our syringes are filled with saline.(b)(4).

Event Description

It was reported that a nurse noticed green and black particulate that looked like mold in a 10 ml bd posiflush¿ normal saline syringe.This was noticed before administration and the device was brought to the pharmacy.There was no report of injury or medical intervention.It was also reported that approximately ten devices were quarantined from the pharmacy.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• 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: 6605257
• MDR Text Key: 76526937
• Report Number: 1911916-2017-00013
• Device Sequence Number: 1
• Product Code: NGT
• 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: Other
• Type of Report: Initial
• Report Date: 06/01/2017

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 Expiration Date: 08/31/2018
• Device Catalogue Number: 306546
• Device Lot Number: 5237762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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